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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This issue has led to 60 injuries and 23 deaths.

This is a Class I recall by FDA, which is the most serious kind. These devices can cause serious injuries or even death.

Sam Brusco Associate Editor05.16.22

The FDA has confirmed Avanos Medical's recall of its Cortrak*2 intramuscular access device. Since March 21st in 2016, 629 of the devices were recalled in the U.S.

Cortrak*2 aids clinicians to place medical feeding tubes inside the stomach or small bowel of patients who require nutrition via tube.

Cortrak 2 eternal access system https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ The system was recalled because of injury and deaths resulting from nasocentric or Nasogastric tube misplacement, when the device is used to help put these tubes in the right place. A mistake in the placement of an Nasogastric tube or Nasoenteric one could cause severe injury or even death.

According to Avanos' safety communication the company has reported 53 deaths and 60 injuries related to this issue. feeding tube placement The adverse events reported included pneumonia, respiratory failure, perforation, and pneumonia, as well as the pleural effusion.

Cortrak*2 has used the recall to make updates to its guidelines for use. The new instructions contain instructions for users to ensure that the tubes are placed in accordance with the guidelines of the institution before using them to deliver nutrition.

Avanos Medical feeding tube Clinicians were also advised to include the field correction note to the operating manual , and return the acknowledgement form that was included with the notice to Avanos. Avanos plans to give users current labels, along with confirmation of placement of tubes in accordance with the institutional guidelines.


Website: https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical